Clinical trials for brain tumoursCClinical trials for brain tumoursClinical trials for brain tumoursEnglishNeurologyChild (0-12 years);Teen (13-18 years)BrainNervous systemNAAdult (19+)NA2009-08-14T04:00:00ZEric Bouffet, MD, FRCPC8.0000000000000059.00000000000001178.00000000000Flat ContentHealth A-Z<p>An in-depth description of clinical trials for children with brain tumors. Answers provided by Canadian Paediatric Hospitals.</p><h2>What is a clinical trial?</h2> <p>A clinical trial is a research study or scientific experiment that examines the use of drugs or other therapies in treatment. It asks a specific question to try and find better ways of preventing, diagnosing, and treating brain tumours in children. For example, clinical trials could study new schedules of radiation therapy, new chemotherapy drugs, new combinations of known drugs, or new combinations of drugs and radiation. </p> <p>There are four different phases of clinical trials. The most “experimental” stage is Phase I. By the time a treatment reaches a phase III clinical trial, it has been studied well. When a phase III trial is conducted under an organizing group of experts, such as the Children’s Oncology Group, it may also be called a protocol. </p><h2>Key points</h2> <ul><li>There are four phases of a climinal that test toxicity, effectiveness, and how well the drugs work compared to existing drugs</li> <li>Research is important for improving the success of treatments.</li> <li>There are many questions you should ask before allowing your child to participate in a clinical trial.</li></ul>
Essais cliniques et les tumeurs cérébralesEEssais cliniques et les tumeurs cérébralesClinical trials for brain tumoursFrenchNeurologyChild (0-12 years);Teen (13-18 years)BrainNervous systemNAAdult (19+)NA2009-08-14T04:00:00ZEric Bouffet, MD, FRCPC8.0000000000000059.00000000000001178.00000000000Flat ContentHealth A-Z<p>Description approfondie des essais cliniques pour les enfants atteints de tumeurs cérébrales. Réponses des hôpitaux pédiatriques canadiens.</p><p>Un essai clinique est une étude de recherche ou une expérience scientifique qui vise à examiner l’utilisation de médicaments ou d’autres thérapies pendant le traitement. On y pose une question précise afin de tenter de découvrir de meilleures façons de prévenir, de diagnostiquer et de traiter les tumeurs cérébrales chez les enfants. Par exemple, dans le cadre d’essais cliniques, on pourrait étudier de nouveaux calendriers de radiothérapie, de nouveaux médicaments chimiothérapeutiques, de nouvelles combinaisons de médicaments connus ou de nouvelles combinaisons de médicaments et de radiothérapie. </p> <p>Il existe quatre phases différentes d’essais cliniques. La phase la plus « expérimentale » est la phase I. Avant qu’un traitement atteigne l’essai clinique de phase III, il faut bien l’étudier. Quand on mène un essai de la phase III organisé par un groupe d'experts, comme le Children’s Oncology Group, on pourrait aussi l’appeler un protocole. </p><h2>À retenir</h2> <ul><li>Un essai clinique comprend quatre phases qui évaluent la toxicité, l’efficacité et à quel point le médicament fonctionne bien en comparaison à des médicaments existants.</li> <li>La recherche est importante afin d’améliorer le succès des traitements.</li> <li>Vous devriez vous poser plusieurs questions avant de laisser votre enfant participer à un essai clinique.</li></ul>

 

 

Clinical trials for brain tumours1386.00000000000Clinical trials for brain tumoursClinical trials for brain tumoursCEnglishNeurologyChild (0-12 years);Teen (13-18 years)BrainNervous systemNAAdult (19+)NA2009-08-14T04:00:00ZEric Bouffet, MD, FRCPC8.0000000000000059.00000000000001178.00000000000Flat ContentHealth A-Z<p>An in-depth description of clinical trials for children with brain tumors. Answers provided by Canadian Paediatric Hospitals.</p><h2>What is a clinical trial?</h2> <p>A clinical trial is a research study or scientific experiment that examines the use of drugs or other therapies in treatment. It asks a specific question to try and find better ways of preventing, diagnosing, and treating brain tumours in children. For example, clinical trials could study new schedules of radiation therapy, new chemotherapy drugs, new combinations of known drugs, or new combinations of drugs and radiation. </p> <p>There are four different phases of clinical trials. The most “experimental” stage is Phase I. By the time a treatment reaches a phase III clinical trial, it has been studied well. When a phase III trial is conducted under an organizing group of experts, such as the Children’s Oncology Group, it may also be called a protocol. </p><h2>Key points</h2> <ul><li>There are four phases of a climinal that test toxicity, effectiveness, and how well the drugs work compared to existing drugs</li> <li>Research is important for improving the success of treatments.</li> <li>There are many questions you should ask before allowing your child to participate in a clinical trial.</li></ul><h2>Why is research important?</h2> <p>Research is the only way of improving the success of treatments. To show how dramatic the effect of research can be, consider the case of childhood leukaemia. In the early 1970s, when children were diagnosed with leukaemia, there was hardly any chance that they would live. Today, for some types of leukaemia, about 80 children in 100 will survive the disease. This success has been achieved as the result of research. This research took place in the form of clinical trials. Each time a trial showed an improvement with a new type of treatment, this new treatment could be used with more children. </p> <h2>What are the phases of clinical trials?</h2> <p>The phases of a clinical study are as follows:</p> <h2>Phase I: How toxic is the drug?</h2> <p>In Phase I, a new drug is tested to see if it is safe to use in humans. This is because it has been tested in a laboratory and shown some promise. Phase I trials require specific expertise and because of this, very few centres offer this type of trial. </p> <p>The goal of a Phase I trial is not to cure the disease, although researchers hope that the drug will be effective. A small dose is given to 30 or fewer patients. The dose is slowly increased during the trial until harmful side effects appear. This is called the maximum tolerated dose. The previous lower dose is then accepted to be a safe dose. This safe dose is used if the drug moves on for further study in Phase II clinical trials. </p> <h3>Who can participate in a Phase I trial?</h3> <p>Phase I trials are only offered to people whose disease has not been controlled by other treatments. It also depends on type of disease, the overall condition of the patient, and the amount of therapy already received. Few centres offer Phase I trials. </p> <h3>What are the potential benefits?</h3> <p>A Phase I study can help doctors learn how the body reacts to new drugs. Although it is rare, a few of the participants may show response to the drug. The results may help others in the future. </p> <h3>What are the potential harms?</h3> <p>Because the drug is new, the side effects may not be known. Side effects may be serious, and cause pain or discomfort.</p> <h2>Phase II: How do tumours respond to the drug? Which types of tumours can be treated?</h2> <p>In Phase II, a drug is tested on specific types of tumours to see what effect the drug has on a tumour. The trial also studies which types of cancer can be treated with the drug. The safe dose that was established in Phase I is tested on 30 to 100 participants. </p> <h3>Who can participate in a Phase II trial?</h3> <p>Phase II trials are offered to people whose disease has not been controlled by other treatments. It also depends on type of disease, the overall condition of the patient, and the amount of therapy already received. A limited number of treatment centres offer Phase II trials. </p> <h3>What are the potential benefits?</h3> <p>The drug may help some participants. The results may help others in the future.</p> <h3>What are the potential harms?</h3> <p>There may be unexpected and serious side effects. The side effects may cause pain and discomfort.</p> <h2>Phase III: How well does this drug work compared to existing treatments?</h2> <p>By the time a drug or therapy reaches a Phase III clinical trial, it has gone through Phase I and II trials and appears to work. The drug or therapy (combination of drugs) is now compared to the treatment currently used (standard treatment). The goal is to find out which treatment is better. This might be measured by survival rates, side effects, or other outcomes. Participants are randomly assigned to receive one of the two treatments. The trial can involve 100 to 1,000 people. </p> <h3>Who can participate in a Phase III trial?</h3> <p>Phase III trials are offered at certain treatment centres to patients entering care. The exact eligibility depends on the goals of the particular study. </p> <h3>What are the potential benefits?</h3> <p>There is a good chance the drug will help participants. If the drug or therapy proves to be effective in Phase III trials, it may receive government approval to be used for this specific illness. As a result, the drug will eventually be widely available to help or cure many people. </p> <h3>What are the potential harms?</h3> <p>There may be side effects, but these are usually known from Phase I and II. A strategy may be in place to help reduce the side effects. </p> <h2>Questions you may want to ask about a clinical trial</h2> <ul> <li> What is the purpose of the study?</li> <li> What is the phase of the study?</li> <li> What is involved in the treatment plan?</li> <li> What are the benefits of participating?</li> <li> What are the risks of participating?</li> <li> Is there any information about how other children have responded to the same treatment?</li> <li> What are the side effects, both in the short-term and long term? How will the side effects be prevented or managed?</li> <li> Are any extra diagnostic tests required? </li> <li> How will participating in the trial affect my child’s daily life? </li> <li> What effect might this have on other family members?</li></ul> <h2>My child’s treatment has failed. Should I enrol my child in a clinical trial?</h2> <p>If the treatment fails and your child’s tumour has recurred, your doctor may talk about joining a study. There is less information about treating a recurrence, so the options may be more experimental than a study that was offered on diagnosis. The three options may be: </p> <ul> <li> A research protocol. For some tumours that have relapsed, there are protocols coordinated by a national or international group, such as the Children’s Oncology Group (COG) or the International Society for Paediatric Oncology (SIOP). </li> <li> A Phase II clinical trial.</li> <li> A Phase I clinical trial.</li></ul> <p>It is important to ask questions about the trial, and discuss its advantages and disadvantages with your child’s doctor.</p> <h2>What about new drugs? Is there something out there that’s better than what my child has been offered?</h2> <p>There is often news about new drugs or treatment breakthroughs. Parents are more likely to consider new drugs if the first treatment has failed and there is no other promising treatment. Some may think about travelling to other cities or countries to try the new drug or treatment. </p> <p>If you are considering a new drug, it is important to learn as much as you can before you make a decision. It will help to speak to your neuro-oncologist and also get a second opinion. It may also help if you understand how the drug was developed, to get a sense of how “promising” the breakthrough really is. </p> <h2>How are new drugs developed?</h2> <p>Drug development usually takes a lot of time and research. It begins in the laboratory where a drug has shown to have some effect on tumour cells in animals, for example. At this stage, it is called pre-clinical research. </p> <p>After a drug has shown promise, it will be tested in a clinical trial with humans. Clinical trials move through various phases.</p> <p>After each clinical trial, the researchers will write about their findings. They will describe the procedure, the participants, treatment results, side effects, and their understanding of the results. The researchers will send their report to a scientific journal. Other experts who are not connected to the study will read and analyze this report. This is called peer review. If these experts agree that the trial was of high quality, the report will be published. </p> <p>After reading the report, other researchers in different cities and countries should be able to repeat similar trials to see if they get the same results. Larger and larger numbers of patients will participate. </p> <p>After a number of trials that show its effectiveness, a drug or treatment is approved by a national regulatory body, such as Health Canada, the U.S. Food and Drug Administration, or the Medicines Control Agency in the United Kingdom. Usually, it is first approved for a very particular disease and situation. Later trials help pave the way for the drug to be approved for use with different diseases or age groups. </p> <p>This long process shows why the discovery of “miracle cures” in science is so rare. Scientific discovery moves in small steps. Each of these steps involves a clinical trial that takes a great deal of time, effort, collaboration, and thought by many different researchers. </p> <p>This scientific process is not always perfect — for example, some journals have higher standards than others — but it is the best way to make sure that a new treatment is safe and effective. </p>Clinical trials for brain tumours

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